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Study of INCB039110 in Combination With Docetaxel in Subjects With Non-Small Cell Lung Cancer | Clinical Trials | Clareo Health

TERMINATEDPHASE2

Study of INCB039110 in Combination With Docetaxel in Subjects With Non-Small Cell Lung Cancer

A Randomized, Phase 2 Study of INCB039110 or Placebo in Combination With Docetaxel in Subjects With Previously Treated Stage IIIb, IV, or Recurrent Non-Small Cell Lung Cancer

NCT02257619•Incyte Corporation

View on ClinicalTrials.gov

Summary

The primary objectives of this study is to evaluate the safety and tolerability of itacitinib in combination with docetaxel and to select doses for further evaluation (Part 1, safety run-in portion).

Detailed Description

Sponsor decision to not initiate part 2 of the trial and Part 2 of the study was not conducted. In Part 2, the randomized portion, the objective is to evaluate and compare the overall survival of subjects with previously treated advanced or metastatic non-small cell lung cancer (NSCLC) when treated with itacitinib in combination with docetaxel versus docetaxel alone. The secondary objectives of this study (Part 2) are to evaluate and compare the efficacy of the 2 treatment groups with respect to progression-free survival, overall tumor response, and duration of response, and to evaluate and compare disease control, safety, and tolerability of itacitinib in combination with docetaxel versus docetaxel alone.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Histologically or cytologically confirmed diagnosis of NSCLC that is Stage IIIb, IV, or recurrent.
•2. Received only 1 prior systemic chemotherapy regimen for Stage IIIb, IV, or recurrent disease not including neoadjuvant and/or adjuvant therapy. (NOTE: Exceptions may be allowed based on prior treatment regimens and tumor types in agreement with protocol requirements.)
•3. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
•4. Life expectancy of ≥12 weeks.

Exclusion Criteria

•1. Received prior treatment with docetaxel.
•2. Known active central nervous system (CNS) metastases. Subjects with CNS metastases who have completed a course of therapy would be eligible for the study provided they are clinically stable for at least 1 month prior to study entry, defined as:
•1. No evidence of new or enlarging CNS metastasis or new neurological symptoms attributable to CNS metastases.
•2. Subjects who are receiving concomitant corticosteroids must be on a stable or decreasing dose for at least 4 weeks prior to first dose of study treatment and off all anticonvulsants for at least 4 weeks prior to study entry.
•3. Peripheral neuropathy ≥ Grade 3.
•4. Current or previous other malignancy within 2 years of study entry, except cured basal or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or other noninvasive malignancy.
•5. Significant, concurrent, uncontrolled medical condition including but not limited to, renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, cerebral, or psychiatric disease.
•6. Unwilling to be transfused with blood components.

Locations (16)

Hot Springs, Arizona, United States

Los Angeles, California, United States

Washington D.C., District of Columbia, United States

Orlando, Florida, United States

Detroit, Michigan, United States

Pascagoula, Mississippi, United States

Kansas City, Missouri, United States

Omaha, Nebraska, United States

Lebanon, New Hampshire, United States

Goldsboro, North Carolina, United States

Key Dates

Start Date

September 1, 2014

Primary Completion Date

February 1, 2016

Completion Date

April 1, 2016

Last Updated

January 25, 2018

Enrollment

ACTUAL participants

Conditions

NSCLC (Non-small Cell Lung Carcinoma)

Interventions

Itacitinib

DRUG

docetaxel

DRUG

Low Dose Nivolumab With Chemotherapy vs Standard Chemotherapy as First-Line Treatment in Advanced or Metastatic NSCLC

NCT07050043

NSCLC (Non-small Cell Lung Carcinoma)First Line Therapy+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 25, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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